The National Drug Authority (NDA) may be set up before December 2006 and an implementation committee has already been constituted which is entrusted with the responsibility of setting targets in this direction, according to Dr RA Mashelkar, Director General, CSIR.
It may be recalled the Task Force constituted under the chairmanship of Dr Pronab Sen to explore issues other than price control to make available life-saving drugs at reasonable prices, also had recommended setting up of NDA.
Meanwhile, sources pointed out the demand to set up an NDA is not new. The idea of setting up of National Drug Authority (NDA) started with the Haathi committee report, which, under Chapter IV stated that: "The committee believes that health care has a direct relationship with socio- economic growth of the country and a welfare state should treat production, procurement and distribution of essential drugs, as a social responsibility just as import as ensuring supply of food and shelter. With a view to tackling the problem of large scale production and distribution of drugs, the Committee recommends the creation of a Statutory Body which may be called the National Drug Authority of India (NDA)."
The report had mentioned several functions for NDA. The Government of India, however, did not accept this recommendation and no action was taken for creating NDA. Thus the Drug Policy formulated by Government of India for the first time in 1978 did not include the concept of NDA.
The concept of NDA was again included in the Policy Document of 1986, titled "Measures for Rationalisation, Quality Control and Growth of Drugs and Pharmaceutical Industry in India." In this document, in Part -III, under the main heading "Rational use of Drugs" with sub-heading, 3.1 "Registration of new formulations, Rationalization of Existing Formulations and Creation of the National Drug Authority," it is stated -"New formulations based on Drugs already approved for use in the country would not be allowed to be manufactured unless their therapeutic efficacy and rationality are adequately tested and proved. A machinery called the National Drug and Pharmaceutical Authority would be established at the Central level, with a permanent secretariat."
The Drug Policy announced in 1994 once again envisaged setting up of an independent body called NDA. It was to be set up by an Act of Parliament for providing a more efficient mechanism for ensuring quality control and rational use of medicines.
In 1999, the ministry appointed a consultant to examine the existing legal and operational framework of drug control system in India, and to suggest available options for the organizational structure of the proposed NDA. For reasons of complexities involved, the government was not able to set up NDA during the period 1994-2000.
In the Policy document of 2002, the government indicated its preference that the ministry of health & family welfare would "set up a world class Central Drug Standard Control Organisation (CDSCO) by modernizing, restructuring and reforming the existing system and establish an effective net work of drugs standards enforcements administrations in the states with the CDSCO as a nodal centre, to ensure high standards of quality, safety and efficacy of drugs and pharmaceuticals." Thus, the Pharmaceutical Policy 2002 opted for a world class CDSCO, rather than NDA.
K Subbi Reddy, deputy director of Andhra Pradesh Drugs Control Administration (APDCA), said, “Setting up of NDA will be critical and vital for the country, as scrutinizing the drugs that are marketed in the country will become more effective. This will lay a right platform for uniform policy, as Dr Mashelkar proposed.” Despite Haathi Committee’s recommendation about thirty years ago, NDA’s existence hasn’t yet become a reality. There is also a need for modifying the Drugs and Cosmetics Act, in addition to creation of NDA, he added.